IP Library › Granted Patent US 12674805
Granted Patent B2
US 12674805 · App. 17/638,746 · Granted Jul 7, 2026

Compliance method

Inventors: Michael McEwan (London, GB); George Grant Hardie (London, GB); Oscar Camacho (London, GB)
Assignee: NICOVENTURES TRADING LIMITED
G01N33/6893G01N2800/307G01N2800/52
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Quick Facts
Patent No.
US 12674805
App. No.
17/638,746
Granted
Jul 7, 2026
Kind
B2
Abstract

The present disclosure relates to methods incorporating the use of a biomarker (CEVal) for assessing compliance with a smoking cessation program, for example, a smoking cessation program which involves subjects switching from conventional cigarettes to a hybrid device, an e-cigarette and/or a tobacco heating product, a smoking cessation program involving the use of nicotine replacement therapy, a smoking cessation program involving lifestyle choices or therapy, or a combination thereof.

Claims (72)

1 . A method of assessing compliance with a smoking cessation program, said method comprising:

(a) providing one or more blood samples from a subject;

(b) measuring the level of N-(2-cyanoethyl) valine (CEVal) from the one or more blood samples of the subject in a biological assay;

(c) comparing the level obtained in step (b) with reference levels of CEVal for the smoking cessation program; and

(d) stratifying the subject according to compliance with the smoking cessation program based on the comparison in step (c); and

(e) modifying or maintaining the smoking cessation program for the subject based on the stratification in step (d);

wherein the smoking cessation program comprises switching from combustible smoking articles to a non-combustible aerosol provision system, nicotine replacement therapy, lifestyle choices, therapy or a combination thereof;

wherein the reference levels of CEVal are indicative of compliance or non-compliance with the smoking cessation program, or indicative of compliance, partial compliance or non-compliance with the smoking cessation program;

wherein the smoking cessation program has a length of at least 80 days and wherein the reference CEVal levels at about day 80 to about day 100 of the smoking cessation program are:

i. <about 78 to <about 40 pmol/g Hb CEVal for compliance; and

ii. ≥60 to ≥about 78 pmol/g Hb CEVal for non-compliance;

provided that (i) and (ii) are different; or

i. <about 78 to <about 40 pmol/g Hb CEVal for compliance;

ii. between about 60 and about 164 pmol/g Hb CEVal for partial compliance; and

iii. >about 78 to >about 164 pmol/g Hb CEVal for non-compliance;

provided that (i), (ii) and (iii) are different.

2 . The method of claim 1 , wherein steps (a), (b), (c) and (d) are carried out repeatedly during the course of the smoking cessation program to assess the subject's continued compliance.

3 . The method of claim 1 , wherein the reference CEVal levels at about day 170 to about day 190 of the smoking cessation program are:

i. <about 54 to <about 35 pmol/g Hb CEVal for compliance; and

ii. ≥about 35 to ≥about 54 pmol/g Hb CEVal or greater for non-compliance, provided that (i) and (ii) are different;

or

i. <about 54 to <about 35 pmol/g Hb CEVal for compliance;

ii. between about 35 and about 112 pmol/g Hb CEVal for partial compliance; and

iii. >about 60 to >about 112 pmol/g Hb CEVal for non-compliance;

provided that (i), (ii) and (iii) are different.

4 . The method of claim 1 , wherein the reference CEVal levels at about day 350 to about day 370 of the smoking cessation program are:

i. <about 35 to <about 20 pmol/g Hb CEVal for compliance; and

ii. ≥about 20 to ≥about 35 pmol/g Hb CEVal for non-compliance

provided that (i) and (ii) are different;

or

i. <about 35 to <about 20 pmol/g Hb CEVal for compliance;

ii. between about 20 and about 78 pmol/g Hb CEVal for partial compliance; and

iii. >about 40 to >about 78 pmol/g Hb CEVal for non-compliance;

provided that (i), (ii) and (iii) are different.

5 . A method of assessing compliance with a smoking cessation program, said method comprising:

(a) providing one or more blood samples from a subject;

(b) measuring the level of N-(2-cyanoethyl) valine (CEVal) from the one or more blood samples of the subject in a biological assay;

(c) comparing the level obtained in step (b) with reference levels of CEVal for the smoking cessation program;

(d) stratifying the subject according to compliance with the smoking cessation program based on the comparison in step (c); and

(e) modifying or maintaining the smoking cessation program for the subject based on the stratification in step (d);

wherein the smoking cessation program comprises switching from combustible smoking articles to a non-combustible aerosol provision system, nicotine replacement therapy, lifestyle choices, therapy or a combination thereof;

wherein the reference levels of CEVal are indicative of compliance or non-compliance with the smoking cessation program, or indicative of compliance, partial compliance or non-compliance with the smoking cessation program;

wherein the smoking cessation program has a length of at least 80 days and wherein the reference CEVal levels at about day 80 to about day 100 of the smoking cessation program are:

i. <about 78 to <about 40 pmol/g Hb CEVal for compliance;

ii. between about 60 and about 150 pmol/g Hb CEVal for partial compliance; and

iii. >about 78 to >about 150 pmol/g Hb CEVal for non-compliance;

provided that (i), (ii) and (iii) are different.

6 . The method of claim 5 , wherein the reference levels are:

i. <about 76 pmol/g Hb CEVal for compliance;

ii. between about 76 and about 142 pmol/g Hb CEVal for partial compliance; and

iii. >about 142 pmol/g Hb CEVal for non-compliance;

provided that (i), (ii) and (iii) are different.

7 . The method of claim 5 , wherein the reference CEVal levels at about day 170 to about day 190 of the smoking cessation program are:

i. <about 45 to <about 25 pmol/g Hb CEVal for compliance;

ii. between about 25 and about 100 pmol/g Hb CEVal for partial compliance; and

iii. >about 45 to >about 100 pmol/g Hb CEVal for non-compliance;

provided that (i), (ii) and (iii) are different.

8 . The method of claim 7 , wherein the reference levels are:

i. <about 25 pmol/g Hb CEVal for compliance;

ii. between about 25 and about 77 pmol/g Hb CEVal for partial compliance; and

iii. >about 77 pmol/g Hb CEVal for non-compliance;

provided that (i), (ii) and (iii) are different.

9 . The method of claim 5 , wherein the reference CEVal levels at about day 350 to about day 370 of the smoking cessation program are:

i. <about 25 to <about 10 pmol/g Hb CEVal for compliance;

ii. between about 10 and about 40 pmol/g Hb CEVal for partial compliance; and

iii. >about 20 pmol/g Hb CEVal for non-compliance,

provided that (i), (ii) and (iii) are different.

10 . The method of claim 9 , wherein the reference levels are:

i. <about 10 pmol/g Hb CEVal for compliance;

ii. between about 10 and about 22 pmol/g Hb CEVal for partial compliance; and

iii. >about 22 pmol/g Hb CEVal for non-compliance,

provided that (i), (ii) and (iii) are different.